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A Trial to Investigate Efficacy, Safety and Tolerability of FE 201836 for Nocturia Due to Nocturnal Polyuria in Adults (DAWN)

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ClinicalTrials.gov Identifier: NCT03201419
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 26, 2017
First Posted Date  ICMJE June 28, 2017
Last Update Posted Date June 12, 2020
Actual Study Start Date  ICMJE July 27, 2017
Actual Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
Change from baseline in number of nocturnal voids [ Time Frame: during 12 weeks of treatment ]
Nocturnal voids are defined as voids occuring from 5 minutes after bedtime until rising in the morning
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2018)
  • Change from baseline in number of nocturnal voids [ Time Frame: Week 1, 4, 8 and 12 ]
    Nocturnal voids are defined as voids occuring from 5 minutes after bedtime until rising in the morning
  • Responder rate in nocturnal voids [ Time Frame: Week 1, 4, 8 and 12 and during 12 weeks of treatment ]
    Defined as 50% reduction in nocturnal voids from baseline
  • Change from baseline in Nocturia Impact (NI) Diary Total Score [ Time Frame: Week 1, 4, 8 and 12 and during 12 weeks of treatment ]
    Assessed by scores from 0-4 of 11 core items
  • Change from baseline in NI Diary Overall Impact Score [ Time Frame: Week 1, 4, 8 and 12 and during 12 weeks of treatment ]
    Assessed by 1 overall Quality of Life (QoL) question
  • Patient Global Impression of Improvement (PGI-I) urinary symptoms scores [ Time Frame: Week 1, 4, 8 and 12 ]
    Assessed by a patient questionnaire (summary of change in nocturia coded from 1-7)
  • Change from baseline in Patient Global Impression of Severity (PGI-S) scores [ Time Frame: Week 1, 4, 8 and 12 ]
    Assessed by a patient questionnaire (summary of severity of nocturia symptoms coded from 1-4)
  • Change from baseline in Bother [ Time Frame: Week 1, 4, 8 and 12 ]
    Assessed by the Hsu 5-point Likert Bother scale
  • Change from baseline in Insomnia Severity Index (ISI) [ Time Frame: Week 4, 8 and 12 ]
    Assessed by a patient questionnaire.
  • Change from baseline in First Undisturbed Sleep Period (FUSP) [ Time Frame: Week 1, 4, 8 and 12 and during 12 weeks of treatment ]
    FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occured
  • Change from baseline in nocturnal diuresis rate (hourly) profiles [ Time Frame: Week 1 and 12 ]
    The nocturnal diuresis rate (mL/min) is calculated from the mean of 3 days Nocturnal Urine Volume (NUV) and total time in bed
  • Change from baseline in NUV [ Time Frame: Week 1 and 12 ]
    NUV is defined as the total urine volume from 5 minutes after bedtime with the intention to sleep until the first void within 30 minutes of rising in the morning
  • Nights with at most one nocturnal void [ Time Frame: During 12 weeks of treatment ]
    Calculated as percentage of nights during the treatment period
  • Nights with no nocturnal voids [ Time Frame: During 12 weeks of treatment ]
    Calculated as percentage of nights during the treatment period
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2017)
  • Change from baseline in number of nocturnal voids [ Time Frame: Week 1, 4, 8 and 12 ]
    Nocturnal voids are defined as voids occuring from 5 minutes after bedtime until rising in the morning
  • Responder rate in nocturnal voids [ Time Frame: Week 1, 4, 8 and 12 and during 12 weeks of treatment ]
    Defined as 50% reduction in nocturnal voids from baseline
  • Change from baseline in Nocturia Impact (NI) Diary Total Score [ Time Frame: Week 1, 4, 8 and 12 and during 12 weeks of treatment ]
    Assessed by scores from 0-4 of 11 core items
  • Change from baseline in NI Diary Overall Impact Score [ Time Frame: Week 1, 4, 8 and 12 and during 12 weeks of treatment ]
    Assessed by 1 overall Quality of Life (QoL) question
  • Patient Global Impression of Improvement (PGI-I) urinary symptoms scores [ Time Frame: Week 1, 4, 8 and 12 ]
    Assessed by a patient questionnaire (summary of change in nocturia coded from 1-7)
  • Change from baseline in Patient Global Impression of Severity (PGI-S) scores [ Time Frame: Week 1, 4, 8 and 12 ]
    Assessed by a patient questionnaire (summary of severity of nocturia symptoms coded from 1-4)
  • Change from baseline in Bother [ Time Frame: Week 1, 4, 8 and 12 ]
    Assessed by the Hsu 5-point Likert Bother scale
  • Change from baseline in Insomnia Severity Index (ISI) [ Time Frame: Week 4, 8 and 12 ]
    Assessed by a patient questionnaire.
  • Change from baseline in First Undisturbed Sleep Period (FUSP) [ Time Frame: Week 1, 4, 8 and 12 and during 12 weeks of treatment ]
    FUSP is defined as the time in minutes from the time of going to bed to the time of first nocturnal void, or time of awakening if no void occured
  • Change from baseline in nocturnal diuresis rate (hourly) profiles [ Time Frame: Week 1 and 12 ]
    The nocturnal diuresis rate (mL/min) is calculated from the mean of 3 days Nocturnal Urine Volume (NUV) and total time in bed
  • Change from baseline in NUV [ Time Frame: Week 1 and 12 ]
    NUV is defined as the total urine volume from 5 minutes after bedtime with the intention to sleep until the first void within 30 minutes of rising in the morning
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial to Investigate Efficacy, Safety and Tolerability of FE 201836 for Nocturia Due to Nocturnal Polyuria in Adults
Official Title  ICMJE A Randomised, Double-blind, Placebo-controlled, Response-adaptive Dose-finding Trial Investigating the Efficacy, Safety and Tolerability of Oral Doses of FE 201836, With Desmopressin Orally Disintegrating Tablet as a Benchmark, During 12 Weeks of Treatment for Nocturia Due to Nocturnal Polyuria in Adults
Brief Summary The purpose of this trial is to investigate the efficacy, safety and tolerability of different oral doses of FE 201836, with desmopressin as a benchmark, during 12 weeks of treatment for nocturia due to nocturnal polyuria in adults
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Following randomisation, the first 125 subjects will be treated daily with placebo, FE 201836 or desmopressin for up to 12 weeks. Subjects may hereafter be randomised to one of 8 treatment groups for 12 weeks: placebo, 6 different doses of FE 201836, or desmopressin
Masking: Double (Participant, Investigator)
Masking Description:
Each subject will receive 2 medications (an oral solution and an orally disintegrating tablet (ODT) formulation) throughout the trial, in order to keep the treatment blinded.
Primary Purpose: Treatment
Condition  ICMJE Nocturia
Intervention  ICMJE
  • Drug: FE 201836
    Oral solution for daily intake
  • Drug: Desmopressin
    Desmopressin Orally Disintegrating Tablet (ODT)
    Other Name: NOCDURNA
  • Drug: Placebo oral solution
    Manufactured to mimic experimental drug
  • Drug: Placebo ODT
    Manufactured to mimic active comparator drug
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo oral solution
    • Drug: Placebo ODT
  • Active Comparator: Desmopressin
    Desmopressin ODT (25 μg for females and 50 μg for males)
    Interventions:
    • Drug: Desmopressin
    • Drug: Placebo oral solution
  • Experimental: FE 201836 (1)
    Dose 1
    Interventions:
    • Drug: FE 201836
    • Drug: Placebo ODT
  • Experimental: FE 201836 (2)
    Dose 2
    Interventions:
    • Drug: FE 201836
    • Drug: Placebo ODT
  • Experimental: FE 201836 (3)
    Dose 3
    Interventions:
    • Drug: FE 201836
    • Drug: Placebo ODT
  • Experimental: FE 201836 (4)
    Dose 4
    Interventions:
    • Drug: FE 201836
    • Drug: Placebo ODT
  • Experimental: FE 201836 (5)
    Dose 5
    Interventions:
    • Drug: FE 201836
    • Drug: Placebo ODT
  • Experimental: FE 201836 (6)
    Dose 6
    Interventions:
    • Drug: FE 201836
    • Drug: Placebo ODT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2019)
302
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2017)
300
Actual Study Completion Date  ICMJE October 31, 2019
Actual Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adults ≥18 years of age (at the time of written consent)
  • Medical history of, or subject reported nocturia symptoms during the 6 months prior to Visit 1
  • ≥2 nocturnal voids (an average over 3 days) as documented in the 3-day e-Diary prior to Visit 2
  • The largest single voided volume must be ≥200 mL (at least 1 void ≥200 mL) as documented in the 3-day e-Diary prior to Visit 2
  • Nocturnal polyuria, defined as Nocturnal Polyuria index >33%, a ratio of Nocturnal Urine Volume in excess of 33% of total daily (24-hour) urine volume as documented in the 3-day e-Diary prior to Visit 2
  • ≥20% decrease in the nocturnal diuresis rate (mL/min) (that was recorded at Visit 2) as documented in the 3-day e-Diary prior to Visit 3

Exclusion Criteria:

  • Current diagnosis of Obstructive Sleep Apnoea (OSA)
  • Restless Legs Syndrome (RLS)
  • Bladder Outlet Obstruction (BOO) or urine flow <5 mL/s, as confirmed by uroflowmetry upon suspicion during screening prior to Visit 2
  • Urinary incontinence defined as an average of >1 episode/day in the 3-day e-Diary prior to Visit 2 (occasional urge incontinence during daytime or at night on the way to void is not necessarily exclusionary)
  • Any pelvic or lower urinary tract surgery and/or radio therapy or previous pelvic irradiation within the past 6 months prior to Visit 1. Including e.g., transurethral resection for Bladder Outlet Obstruction or Benign Prostatic Hyperplasia, hysterectomy or female incontinence procedures
  • Genito-urinary tract pathology that can in the investigator's opinion be responsible for urgency or urinary incontinence e.g., symptomatic or recurrent urinary tract infections, interstitial cystitis, bladder-related pain, chronic pelvic pain syndrome, or stone in the bladder or urethra causing symptoms
  • A history of cancer with the last date of disease activity/presence of malignancy within the last 12 months prior to Visit 1, except for adequately treated basal cell carcinoma of the skin
  • History of any neurological disease affecting bladder function or muscle strength (e.g., Multiple Sclerosis, Parkinson's, spinal cord injury, spina bifida)
  • Habitual (fluid intake >3L per day) or psychogenic polydipsia
  • Uncontrolled hypertension, as judged by the investigator
  • Uncontrolled diabetes mellitus, as judged by the investigator
  • Central or nephrogenic diabetes insipidus
  • Known history of Syndrome of Inappropriate Antidiuretic Hormone (SIADH) secretion
  • History of gastric retention
  • Suspicion or evidence of congestive heart failure, (New York Heart Association (NYHA) class II, III, IV)
  • Hyponatraemia:

    • Serum sodium level <135 mmol/L at Visit 1(re-tested, with results available within 7 days)
    • Serum sodium level <130 mmol/L at Visit 3 (re-tested, with results available within 7 days)
  • Use of any prohibited therapy listed below:

    • Current or former (within 3 months prior to screening) treatment with any other investigational medicinal product (IMP)
    • Unstable electrostimulation or behavioural bladder training program less than 3 months prior to screening (stable electrostimulation or behavioural bladder training program started at least 3 months before screening are acceptable)
    • Thiazide diuretics
    • Antiarrhythmic agents
    • V2-receptor antagonists/agonists (e.g., vaptans/desmopressin, vasopressin)
    • Loperamide
    • Botulinum toxin (cosmetic non-urological use is acceptable)
    • Valproate
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   Czechia,   Germany,   Hungary,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03201419
Other Study ID Numbers  ICMJE 000233
2016-003851-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Compliance Ferring Pharmaceuticals
PRS Account Ferring Pharmaceuticals
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP